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CPhI Worldwide announces the winners of the 16th Pharma Awards

CPhI Worldwide announces the winners of the 16th Pharma Awards
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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...
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CPhI Worldwide, organised by Informa PLC, announce the winners of the prestigious 2019 CPhI Pharma Awards – celebrating the industry’s top innovators, performers and outstanding achievements across 13 categories, spanning the entire industry supply chain. The winners have been recognised for delivering excellence in pharma and were unveiled during an invitation only ceremony on the opening evening of CPhI Worldwide in Frankfurt.

The prestigious ‘CEO of the Year’ award has been bestowed upon Dr. Ge Li, Founder, Chairman and CEO of WuXi AppTec who was chosen for his significant contribution to the global biopharma R&D industry. Under his leadership, WuXi AppTec has become a highly respected contributor to global healthcare innovation. The company is enabling more than 3,700 customers and partners in more than 30 countries by offering open-access capabilities and services, accelerating the discovery and development of new medicines for patients around the world.

For the second time in three years, Cambrex was awarded the ‘API Development’ category for their Crystallisation Screening and Process Development Service. The service has bridged the gap between the bench and manufacturing plat, providing controlled, robust and scalable crystallization processes. Hovione received a ‘highly commended’ acknowledgement for their Process Ranking of Inputs from Manufacturing (PRIME)

John Chiminski, Chair and CEO at Catalent Pharma Solutions, won the ‘Lifetime Achievement’ award for his accomplishments spanning more than three decades. These include the last 10 years at Catalent, during which time the company has become a true benchmark of advanced delivery technologies, development, and manufacturing solutions.

The ‘Formulation’ award was given to Nanoform for its controlled expansion of supercritical solutions (CESS®). Spraying Systems Co. / Fluid Air Inc. were bestowed with the ‘Manufacturing Technology and Equipment’ award for their PolarDry®’ – the Cooler Technology. Cited as the future of spray drying, it utilises electrostatic technology to prevent against API loss, degradation, and denaturalisation.

Univercells received the ‘Bioprocessing and Manufacturing’ award in recognition of its NevoLine PlatformTM, which is a bioproduction system for vaccines. The ‘Regulatory Procedures and Compliance’ prize was given to Merck Healthcare KGaA for ‘Project SARA’ (Smart Assistant for Regulatory Affairs).

The ‘Analysis, Testing, and Quality Control’ category was claimed by MedPharm for pioneering the regulatory approval of topical products using in vitro bioequivalence. MedPharm is the first contract research organisation to gain regulatory approval using in vitro models to demonstrate the bioequivalence of a generic formulation compared to the originator.

SCHOTT Pharmaceutical Systems and W.L. Gore & Associates received the ‘Packaging’ award for its syriQ BioPure® – a silicone-free syringe – whilst Hoffmann Neopac was highly commended for their STYLO Spatula applicator.

The winner of the ‘Pharma Service Company of the Year Award’ is Lonza Pharma & Biotech. The company is recognised for its integrated global services offering that spans the pharmaceutical, biotech, consumer health and specialty chemicals market.

In ‘Contract Services and Outsourcing’ Nanopharm Ltd – an Aptar pharma company – was selected as the winner for SmartTrack™, with CMAC being highly commended for their CMAC National Facility. Finally, the award for ‘Drug Delivery and Devices’ was given to Phillips-Medisize for its Connected Health Platform, and the ‘Supply Chain, Logistics and Distribution’ category was given to Kemiex AG.

Tara Dougal, Head of Content at Informa, commented: “The judges noted that this year our entries possessed an extremely high standard. All of the finalists would have would have made outstanding winners in previous years. On behalf of CPhI Worldwide, I would like to extend my congratulations to all the winners and commend all of the finalists. What you are doing is of tremendous benefit to the industry, but more importantly, it is also directly contributing to improved patient experiences globally”.

For more information on the CPhI Pharma Awards please visit: http://awards.cphi.com/

The 2019 CPhI Pharma Award winner by category:

  • Excellence in Pharma: Analysis, Testing, and Quality Control – MedPharm regulatory approval of topical products using in vitro bioequivalence
  • Excellence in Pharma: API Development ­– Cambrex crystallisation screening and process development service. Highly commended – Hovione process ranking of inputs from manufacturing
  • Excellence in Pharma: Bioprocessing & Manufacturing – Univercells The NevoLine PlatformTM
  • Excellence in Pharma: Contact Services and Outsourcing – Nanopharm Ltd, an Aptar Pharma Company Smart Track. Highly commended – CMAC, CMAC National Facility
  • Excellence in Pharma: Formulation – Nanoform Controlled Expansion of Supercritical Solutions
  • Excellence in Pharma: Manufacturing Technology and Equipment – Spraying Systems Co./Fluid Air Inc PolarDry The Cooler Technology
  • Excellence in Pharma: Drug Delivery Devices – Phillips-Medisize Connected Health Platform
  • Excellence in Pharma: Packaging – SCHOTT Pharmaceutical Systems and W.L Gore & Associates syriQ BioPure silicone-free syringes with GORE ImproJect Plungers. Highly commended – Hoffman Neopac STYLO Spatula applicator for Canseten footcare Cream Bayer Consumer Health
  • Excellence in Pharma: Regulatory Procedures and Compliance – Merck Healthcare KGaA Project SARA (Smart Assistant for Regulatory Affairs)
  • Excellence in Pharma: Supply Chain Logistics and Distribution – Kemlex AG Trade Network for Life Sciences Raw Materials
    CEO of the Year: Dr. Ge Li, Founder, Chairman & CEO, WuXi AppTec
  • Pharma Service Company of the Year: Lonza Pharma & Biotech
  • Lifetime Achievement Award: John Chiminski, Chair and CEO at Catalent Pharma Solutions

About CPhI

CPhI drives growth and innovation at every step of the global pharmaceutical supply chain from drug discovery to finished dosage. Through exhibitions, conferences and online communities, CPhI brings together more than 100,000 pharmaceutical professionals each year to network, identify business opportunities and expand the global market. CPhI hosts events in Europe, Korea, China, India, Japan, South East Asia, North America, and the Middle East and Africa. Co-locating with ICSE for contract services; P-MEC for machinery, equipment & technology; InnoPack for pharmaceutical packaging; bioLIVE for biopharma; and Finished Dosage Formulation for every aspect of the finished dosage supply chain. CPhI provides an online buyer and supplier directory at CPhI-Online.com.

For more information visit https://www.cphi.com

About Informa Markets

Informa Markets creates platforms for industries and specialist markets to trade, innovate and grow. Our portfolio is comprised of more than 550 international B2B events and brands in markets including Healthcare & Pharmaceuticals, Infrastructure, Construction & Real Estate, Fashion & Apparel, Hospitality, Food & Beverage, and Health & Nutrition, among others. We provide customers and partners around the globe with opportunities to engage, experience and do business through face-to-face exhibitions, specialist digital content and actionable data solutions. As the world’s leading exhibitions organiser, we bring a diverse range of specialist markets to life, unlocking opportunities and helping them to thrive 365 days of the year.

For more information, please visit www.informamarkets.com.

 

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...
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